塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073014097301389630135343010921301366330132220.05
210.083008861300865730087590.01
单位质量响应值RSD%判断
299227.61298488.000.18数据可信
供试品溶液-25010701-2批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1338874-33887411.29411.726.9711.2911.726.95
2363321-36332112.10812.11
3377851-37785112.59312.59
4346431-34643111.54511.55
5311650-31165010.38610.39
6371282-37128212.37412.37
10min1865487-86548728.84429.775.9228.8629.785.92
2898556-89855629.94629.96
3948298-94829831.60431.62
4885701-88570129.51829.54
5810716-81071627.01927.03
6950228-95022831.66831.69
15min11311525-131152543.70945.445.8043.7745.505.79
21375481-137548145.84145.90
31427634-142763447.57947.64
41363909-136390945.45545.52
51242048-124204841.39441.45
61460769-146076948.68348.75
20min11678637-167863755.94457.924.9156.0758.054.92
21759920-175992058.65358.78
31802436-180243660.07060.21
41748655-174865558.27758.41
51602166-160216653.39553.51
61836257-183625761.19761.34
30min12199576-219957673.30574.802.7873.5175.022.79
22270427-227042775.66675.89
32269228-226922875.62675.85
42286714-228671476.20976.43
52139102-213910271.29071.49
62301041-230104176.68776.92
45min12617651-261765187.23887.530.8887.5687.860.89
22643932-264393288.11488.45
32632596-263259687.73688.08
42632330-263233087.72788.06
52584394-258439486.13086.44
62646676-264667688.20688.55
60min12764208-276420892.12392.220.5492.5792.680.55
22777043-277704392.55093.02
32765399-276539992.16292.64
42753876-275387691.77892.24
52751424-275142491.69792.13
62791018-279101893.01693.49
极限12854349-285434995.12795.120.4895.7295.720.49
22874483-287448395.79896.40
32848378-284837894.92895.54
42842412-284241294.72995.33
52840094-284009494.65295.22
62865580-286558095.50196.12
塞来昔布片项目信息
介质体积(ml)1000取样体积(ml)1.5补液体积(ml)1.5
对照品批号510141-202102 对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.6对照品水分(%)0对照品稀释倍数50
标示量(mg)200供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
110.073015065301087730109893012941301101130121770.07
210.082999895299932729996110.02
单位质量响应值RSD%判断
299123.83297580.460.37数据可信
供试品溶液-25010702批-pH6.8(内含0.5%Tween80)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min1345330-34533011.52811.249.8911.5311.249.88
2391797-39179713.08013.08
3341238-34123811.39211.39
4324321-32432110.82710.83
5290515-2905159.6989.70
6326168-32616810.88910.89
10min1881196-88119629.41729.426.6429.4329.446.64
2984427-98442732.86432.88
3865077-86507728.87928.90
4879600-87960029.36429.38
5802753-80275326.79926.81
6874564-87456429.19629.21
15min11355083-135508345.23845.125.6245.3045.185.63
21464274-146427448.88348.95
31300155-130015543.40443.46
41384057-138405746.20546.27
51241022-124102241.43041.48
61365286-136528645.57845.64
20min11763965-176396558.88757.744.3559.0257.874.35
21815483-181548360.60760.75
31680219-168021956.09256.22
41775928-177592859.28759.42
51606800-160680053.64153.76
61734447-173444757.90258.03
30min12284126-228412676.25274.272.6476.4774.482.64
22270458-227045875.79676.03
32201817-220181773.50573.71
42242844-224284474.87475.09
52121536-212153670.82471.02
62227971-222797174.37874.59
45min12574915-257491585.96085.191.3386.2985.511.34
22576508-257650886.01386.36
32534937-253493784.62584.95
42554473-255447385.27785.61
52491544-249154483.17783.48
62578028-257802886.06486.39
60min12685254-268525489.64389.470.8390.1089.920.84
22696760-269676090.02890.50
32657662-265766288.72289.17
42681265-268126589.51089.97
52651470-265147088.51688.94
62708469-270846990.41890.87
极限12787243-278724393.04892.820.4893.6493.410.49
22787914-278791493.07193.68
32768318-276831892.41693.00
42772519-277251992.55793.15
52766263-276626392.34892.91
62799705-279970593.46494.06
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